The following data is part of a premarket notification filed by Maine Standards Company, Llc with the FDA for Validate Heparin Calibration Verification/linearity Test Kit.
| Device ID | K163498 |
| 510k Number | K163498 |
| Device Name: | VALIDATE Heparin Calibration Verification/Linearity Test Kit |
| Classification | Plasma, Coagulation Control |
| Applicant | MAINE STANDARDS COMPANY, LLC 221 US Route 1 Cumberland Foreside, ME 04110 |
| Contact | James Champlin |
| Correspondent | James Champlin MAINE STANDARDS COMPANY, LLC 221 US Route 1 Cumberland Foreside, ME 04110 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-13 |
| Decision Date | 2017-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859110005098 | K163498 | 000 |